(67 days)
The ILT Advancing Mechanism is indicated for use with a guide wire in order to access discreet regions of the vasculature. Once the region has been accessed, the Advancing Mechanism can incrementally advance the guide wire.
The ILT Advancing Mechanism is a detachable handle with a distal luer fitting that can be mated with percutaneous catheters. It is designed to be used in conjunction with percutaneous catheters and steerable guide wires to gain access to locations within the cardiovascular structure that are remote from the site of the insertion. Once accessed, the Advancing Mechanism can incrementally advance or retract the steerable guide wire in an occlusion.
The Advancing Mechanism is approximately five inches in length and can be operated with one hand. When the Advancing Mechanism is engaged, each click of the handle advances or retracts the quide wire an average of 0.26 ± 0.05mm. This mechanism can be disengaged (bypassed) for free movement of the quide wire within the attached catheter.
The ILT Advancing Mechanism is packaged in a Tyvek®/mylar pouch that is heatsealed to form a sterile barrier. The packaged units are sterilized with ethylene oxide gas. The device is provided "STERILE", "Non-Pyrogenic" and is intended for single use only.
The provided document describes the ILT Advancing Mechanism, a medical device for incrementally advancing or retracting a guidewire within the cardiovascular system.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state formal acceptance criteria in a table format. However, it implicitly defines a key performance characteristic:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Incremental advance/retraction of guidewire | Each click advances or retracts the guidewire an average of 0.26 ± 0.05 mm |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "Performance test results indicate that the device satisfies functional performance requirements when used as indicated." and "in vivo bench studies."
- Sample size: Not specified.
- Data provenance: Not specified, but likely from internal testing at IntraLuminal Therapeutics, Inc. (Carlsbad, CA, USA). The studies appear to be prospective bench studies rather than clinical trials with human subjects for performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a mechanical accessory, not an AI or diagnostic device that requires expert ground truth for image interpretation or diagnosis. The ground truth for its performance would be direct physical measurements (e.g., using calipers or an optical measurement system to quantify guidewire movement per click).
4. Adjudication method for the test set
Not applicable, as expert adjudication is not relevant for the performance testing of this mechanical device.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical device, not an AI system or diagnostic tool for image analysis.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical device, not an algorithm. The performance described (0.26 ± 0.05 mm per click) is inherently a standalone performance metric of the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the device's main performance characteristic (incremental movement) would be based on physical measurement standards. For example, precise physical measurement instruments would be used to quantify the distance the guidewire moves with each "click" of the advancing mechanism.
8. The sample size for the training set
Not applicable. This is a mechanical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable due to the reasons stated above.
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JUL 2 6 2002
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
SUBMITTER INFORMATION
| A. | Company Name: | IntraLuminal Therapeutics, Inc |
|---|---|---|
| B. | Company Address: | 6354 Corte del AbetoSuite ACarlsbad, CA 92009 |
| C. | Company Phone: | (760) 918-1820 |
| D. | Company Facsimile: | (760) 918-1823 |
| E. | Contact Person: | Pamela MisajonVice President of Regulatory Affairs andQuality Assurance |
| DEVICE IDENTIFICATION | ||
| A. | Trade Name: | ILT Advancing Mechanism |
| A. | Trade Name: | IET Advancing Mechanism |
| B. | Catalog Number: | A115AM1 |
| C. | Common Name: | Advancing Mechanism |
| D. | Classification Name: | Percutaneous Catheter Accessory |
| E. | Device Class: | Class II (per 21 CFR 870.1250) |
IDENTIFICATION OF PREDICATE DEVICE
The ILT Advancing Mechanism is similar in design, materials, mode of operation and intended use to the IntraLuminal Therapeutics, Inc. ILT 0.014" Catheter cleared under 510(k) K001992 and ILT Deflecting Catheter cleared under 510(k) K010531.
DEVICE DESCRIPTION
The ILT Advancing Mechanism is a detachable handle with a distal luer fitting that can be mated with percutaneous catheters. It is designed to be used in conjunction with percutaneous catheters and steerable guide wires to gain access to locations within the cardiovascular structure that are remote from the site of the insertion. Once accessed, the Advancing Mechanism can incrementally advance or retract the steerable guide wire in an occlusion.
The Advancing Mechanism is approximately five inches in length and can be operated with one hand. When the Advancing Mechanism is engaged, each click of the handle
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advances or retracts the quide wire an average of 0.26 ± 0.05mm. This mechanism can be disengaged (bypassed) for free movement of the quide wire within the attached catheter.
The ILT Advancing Mechanism is packaged in a Tyvek®/mylar pouch that is heatsealed to form a sterile barrier. The packaged units are sterilized with ethylene oxide gas. The device is provided "STERILE", "Non-Pyrogenic" and is intended for single use only.
INTENDED USE
The Safe-Cross Advancing Mechanism is indicated for use with a quide wire in order to access discreet regions of the vasculature. Once the region has been accessed, the Advancing Mechanism can incrementally advance or retract the guide wire in an occlusion.
TECHNOLOGICAL CHARACTERISTICS
The ILT Advancing Mechanism is similar in basic materials, design, construction and mechanical performance to the predicate device.
BIOCOMPATIBILITY AND PERFORMANCE DATA
Biocompatibility testing and in vivo bench studies were conducted to evaluate the biological and performance characteristics of the ILT Advancing Mechanism. Biocompatibility test results indicate that the device materials are biocompatible. Performance test results indicate that the device satisfies functional performance requirements when used as indicated.
CONCLUSIONS DRAWN FROM STUDIES
The results of testing demonstrate that the ILT Advancing Mechanism is substantially equivalent to the predicate devices and is capable of safely and accurately performing the stated intended use.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 6 2002
IntraLuminal Therapeutics, Inc. Ms. Pamela Misajon Vice President of Regulatory Affairs and Ouality Assurance 6354 Corte del Abeto, Suite A Carlsbad, CA 92009
Re: K021638
ILT Advancing Mechanism Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire. Regulatory Class: Class II (two) Product Code: 74 DQX Dated: May 17, 2002 Received: May 20, 2002
Dear Ms. Misajon:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
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Page 2 – Ms. Pamela Misajon
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Nola Tiller
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
| 510(k) Number: | K021638 |
|---|---|
| Device Name: | ILT Advancing Mechanism |
| Indications for Use: | The ILT Advancing Mechanism is indicated for use with a guide wire in order to access discreet regions of the vasculature. Once the region has been accessed, the Advancing Mechanism can incrementally advance the guide wire. |
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
Division of Cardiovascular & Respiratory Devices
K00(k) Number K021638
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.